{"answer":{"query":"Copaxone","resolved_as":"applications","packages":3,"applications":["NDA020622"],"identity":{"application_numbers":["NDA020622"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2008-04-28","latest":"2014-01-29","packages_with_a_start_date":3}},"label_history":{"events_total":52,"non_cmc_events":22,"counts_by_class":{"LABELING":20,"EFFICACY":2},"cmc_events":30,"recent_non_cmc_events":[{"application":"NDA020622","submission_no":121,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-22","documents":[{"type":"Label","date":"2026-06-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020622s121lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020622Orig1s121ltr.pdf","untrusted":true}}],"fact_id":"179c3e1dde636418ca16480d"},{"application":"NDA020622","submission_no":119,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020622s118s119lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020622Orig1s118s119ltr.pdf","untrusted":true}}],"fact_id":"9b3e49508e82446642957024"},{"application":"NDA020622","submission_no":118,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020622s118s119lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020622Orig1s118s119ltr.pdf","untrusted":true}}],"fact_id":"50bfbb7f1c93522aff89e0c1"},{"application":"NDA020622","submission_no":116,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-16","documents":[{"type":"Label","date":"2023-11-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020622s116lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-11-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020622Orig1s116ltr.pdf","untrusted":true}}],"fact_id":"eedfb5a0ff8bfbdabbdc1ab7"},{"application":"NDA020622","submission_no":115,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-01-04","documents":[{"type":"Letter","date":"2023-01-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020622Orig1s115ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-01-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020622s115lbl.pdf","untrusted":true}}],"fact_id":"5661ad196a4ab63a01425f2a"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"AP":2,"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":2,"Discontinued":1},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA020622","product_no":"003","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"COPAXONE","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"40MG/ML","untrusted":true}},{"application":"NDA020622","product_no":"002","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"COPAXONE","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"20MG/ML","untrusted":true}},{"application":"NDA020622","product_no":"001","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"COPAXONE","untrusted":true},"form":{"text":"FOR SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"20MG/VIAL","untrusted":true}}]},"recalls":{"recalls_total":5,"counts_by_class":{"Class II":5},"packages_of_these_applications":3,"most_recent":[{"recall_number":"D-0765-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"f202085232821d6fd7a6bab2"},{"recall_number":"D-0766-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"7445996327745318f092f0e7"},{"recall_number":"D-001-2014","classification":"Class II","status":"Terminated","report_date":"2013-11-27","recall_initiated":"2013-10-24","recalling_firm":{"text":"Teva Pharmaceuticals USA","untrusted":true},"reason":{"text":"Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.","untrusted":true},"packages_named":3,"fact_id":"fcdd459d324e00e60979338c"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Glatiramer Acetate","untrusted":true},"brand":{"text":"Copaxone","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":713588637.07,"claims":107923,"beneficiaries":12092,"average_spending_per_claim_usd":6612.0163178,"fact_id":"eea44abcdf51f8454b845594"},{"year":2021,"gross_spending_usd":556474218.61,"claims":82866,"beneficiaries":9680,"average_spending_per_claim_usd":6715.3503078,"fact_id":"de5622ad174d3817d2d8ca1d"},{"year":2022,"gross_spending_usd":456598002.83,"claims":67063,"beneficiaries":7923,"average_spending_per_claim_usd":6808.4935483,"fact_id":"3848a6fd223cbc7b67e1da66"},{"year":2023,"gross_spending_usd":369370973.63,"claims":54312,"beneficiaries":6385,"average_spending_per_claim_usd":6800.9090741,"fact_id":"814102ff78dba17952803baf"},{"year":2024,"gross_spending_usd":257157760.19,"claims":40460,"beneficiaries":4785,"average_spending_per_claim_usd":6355.8517101,"fact_id":"9a6a7fe8ae1adb67f764e5bc"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":302928.62,"all_states_medicaid_paid_prescriptions":52,"top_states":[{"state":"UT","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":302928.62,"total_reimbursed_usd":302928.62,"packages":1,"covers":"fee_for_service_only","fact_id":"7c993031d27a40df34220505"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":1,"older_year_facts_not_used":45,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"37749693a16ce8e547395e7d","field":"ndc.listing","entity":"ndc:68546031730"},{"fact_id":"6cb696d9065c17841bfd733a","field":"ndc.listing","entity":"ndc:68546032506"},{"fact_id":"f782b13ac185a700aa45220d","field":"ndc.listing","entity":"ndc:68546032512"},{"fact_id":"179c3e1dde636418ca16480d","field":"drug.label_event","entity":"application:NDA020622"},{"fact_id":"9b3e49508e82446642957024","field":"drug.label_event","entity":"application:NDA020622"},{"fact_id":"50bfbb7f1c93522aff89e0c1","field":"drug.label_event","entity":"application:NDA020622"},{"fact_id":"eedfb5a0ff8bfbdabbdc1ab7","field":"drug.label_event","entity":"application:NDA020622"},{"fact_id":"5661ad196a4ab63a01425f2a","field":"drug.label_event","entity":"application:NDA020622"},{"fact_id":"7e7a378da3adb276e46182af","field":"drug.te_code","entity":"application:NDA020622"},{"fact_id":"1752833af4cce1ae51829636","field":"drug.marketing_status","entity":"application:NDA020622"},{"fact_id":"3ae306821bc4ba74f5d7382b","field":"drug.te_code","entity":"application:NDA020622"},{"fact_id":"39cd4efd2b2d0190780de053","field":"drug.marketing_status","entity":"application:NDA020622"},{"fact_id":"bd51b3cf4727ed8c71da5791","field":"drug.marketing_status","entity":"application:NDA020622"},{"fact_id":"f202085232821d6fd7a6bab2","field":"ndc.recall","entity":"ndc:68546032512"},{"fact_id":"7445996327745318f092f0e7","field":"ndc.recall","entity":"ndc:68546031730"},{"fact_id":"fcdd459d324e00e60979338c","field":"ndc.recall","entity":"ndc:68546031730"},{"fact_id":"eea44abcdf51f8454b845594","field":"drug.partd_spending","entity":"drug:glatiramer-acetate|copaxone"},{"fact_id":"de5622ad174d3817d2d8ca1d","field":"drug.partd_spending","entity":"drug:glatiramer-acetate|copaxone"},{"fact_id":"3848a6fd223cbc7b67e1da66","field":"drug.partd_spending","entity":"drug:glatiramer-acetate|copaxone"},{"fact_id":"814102ff78dba17952803baf","field":"drug.partd_spending","entity":"drug:glatiramer-acetate|copaxone"},{"fact_id":"9a6a7fe8ae1adb67f764e5bc","field":"drug.partd_spending","entity":"drug:glatiramer-acetate|copaxone"},{"fact_id":"7c993031d27a40df34220505","field":"ndc.medicaid_state_utilization","entity":"ndc_state:68546032512:UT"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:NDA020622","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}